Ca 125 Antibody Ria

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

PMA Number

P850009 ↗

FDA Product Code

LTK

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

APPR Approved

PMA Supplement

S005 (Normal 180 Day Track)

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• What is the primary purpose of the CA 125 Antibody Radioimmunoassay (RIA) in clinical practice?

  The CA 125 Antibody Radioimmunoassay is designed to measure levels of the epithelial ovarian tumor-associated antigen (CA 125) in patient samples. This biomarker is commonly associated with ovarian cancer and other gynecological conditions, making it useful for monitoring and diagnosing these conditions in a laboratory setting.

• How is the CA 125 Antibody RIA kit supplied, and what are the key handling requirements?

  The CA 125 Antibody RIA is supplied as a kit intended for in vitro diagnostic use, requiring laboratory processing. Since it involves radioisotopes, it must be handled strictly according to standard radioisotope safety protocols. The kit is also designed for single-use only, ensuring accuracy and reliability of results.

• Is this device reusable, or is it intended for single-use only? What does that mean for clinical workflows?

  The CA 125 Antibody RIA is explicitly intended for single-use only, meaning each kit is designed for one test cycle. This ensures precision and avoids cross-contamination risks. Clinically, this means laboratories must order kits in advance based on expected workload and dispose of unused components after opening, adhering to both safety and regulatory guidelines.

• What regulatory pathway does the CA 125 Antibody RIA follow, and what does that imply for its use?

  The device is authorized under an FDA Premarket Approval (PMA) with the designation P850009, adhering to regulatory requirements outlined under 21 CFR 866.6010. This implies the device has undergone rigorous review by the FDA to ensure safety, effectiveness, and proper labeling for its intended diagnostic use in measuring CA 125 levels.

• Are there specific storage or handling conditions mentioned for this device, and why are they important?

  While the exact storage conditions are detailed in the accompanying documentation, the device requires adherence to specified protocols to maintain accuracy and reliability of results. Radioimmunoassays like this are sensitive to environmental factors (e.g., temperature, humidity, or light exposure), so proper storage ensures the integrity of the antibodies and reagents until use. Always follow the manufacturer’s instructions to avoid compromising test validity.